Meal Enjoyment and Tolerance: Sex Differences

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: probe meal

• Registration Number: NCT03408977
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Brief Summary

Aim: to determine the effect of gender on the responses to meal ingestion. Participants (10 men and 10 women) will be instructed to eat a standard dinner the day before, to consume a standard breakfast at home after overnight fast, and to report to the laboratory, where the test meal will be administered 4 h after breakfast. Studies will be conducted in a quiet, isolated room with participants sitting on a chair. Participants will ingest a probe meal up to the level of maximal satiation. The probe meal will be served stepwise (150 Kcal every 5 min). Perception of homeostatic (hunger/satiation, fullness) and hedonic (digestive well-being, mood) sensations will be measured at 5 min intervals 10 min before, during and 20 min after ingestion at 10 min intervals.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-01
• Primary Completion: 2017-12-20
• Status Verified: 2018-01
• Study Completion: 2018-01-08
• Study First Submitted: 2018-01-18
• Study First Submitted QC: 2018-01-18
• Study First Posted: 2018-01-24
• Last Update Submitted: 2018-02-23
• Last Update Posted: 2018-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• non-obese

Exclusion Criteria

• history of gastrointestinal symptoms
• prior obesity
• use of medications
• history of anosmia and ageusia
• current dieting
• alcohol abuse
• psychological disorders
• eating disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Women	probe meal	-
Men	probe meal	-

Primary Outcome Measures

Name	Time	Method
Meal tolerance	100 min	Amount of meal (Kcal) consumed up to the level of maximal satiation (score 5 on a - 5 to + 5 score hunger/satiation scale).

Secondary Outcome Measures

Name	Time	Method
Change in digestive well-being induced by the probe meal	1 day	Change in well-being measured by 10 score scales during and after the probe meal.
Change in fullness sensation induced by the probe meal	1 day	Change in fullness sensation measured by 10 score scales during and after the probe meal.
Change in mood induced by the probe meal	1 day	Change in mood measured by 10 score scales during and after the probe meal.
Change in abdominal discomfort induced by the probe meal	1 day	Change in abdominal discomfort measured by 10 score scales during and after the probe meal.
Change in hunger/satiety induced by the probe meal	1 day	Change in hunger/satiety measured by 10 score scales during and after the probe meal.

Trial Locations

Locations (1)

University Hospital Vall d'Hebron; 🇪🇸 Barcelona, Spain